Newsletter Xagena

Grastek, a sublingual tablet as immunotherapy to treat grass pollen-induced allergic rhinitis with or without conjunctivitis in children and adults, approved by FDA

The FDA ( Food and Drug Administration ) has approved Grastek ( Timothy Grass Pollen Allergen Extract ) tablet for sublingual use [ 2800 Bioequivalent Allergy Units ( BAU ) ].
Grastek is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens.
Grastek is approved for use in persons 5 through 65 years of age. Grastek is not indicated for the immediate relief of allergic symptoms.

The prescribing information for Grastek includes a boxed warning regarding severe allergic reactions. Grastek is contraindicated in patients with severe, unstable or uncontrolled asthma; a history of any severe systemic allergic reaction; a history of any severe local reaction after taking any sublingual allergen immunotherapy; a history of eosinophilic esophagitis; or hypersensitivity to any of the inactive ingredients contained in the product.

Symptoms of grass pollen-induced allergic rhinitis with or without conjunctivitis may include sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes, and typically intensify during the grass pollen season.

Timothy grass is one of the most common grasses in the United States and has been demonstrated to be cross-reactive with other grasses, including sweet vernal, orchard ( also known as cocksfoot ), perennial rye, Kentucky blue ( also known as June grass ), meadow fescue and redtop. Timing of the grass pollen season varies regionally across the United States.

The recommended dose of Grastek is one tablet daily to be placed under the tongue, where it will dissolve. The first dose of Grastek should be administered in a healthcare setting under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases.
The physician should observe the patient for at least 30 minutes after receiving the first dose of Grastek to monitor for signs or symptoms of a severe systemic or a severe local allergic reaction. If the patient tolerates the first dose, the patient may take subsequent doses at home. The physician should prescribe auto-injectable Epinephrine, and instruct and train the patient on its appropriate use. Children must take Grastek under adult supervision.
Initiate Grastek at least 12 weeks before the expected onset of each grass pollen season and continue treatment throughout the season. The safety and efficacy of in-season initiation have not been established.
For sustained effectiveness for one grass pollen season after cessation of treatment, Grastek may be taken daily for three consecutive years ( including the intervals between the grass pollen seasons ). The safety and efficacy of in-season initiation have not been established. ( Xagena )